Unlock the power to be your own CRO.

Clinical Research Coordinator Analysis

Drug Administration and Dietary Adherence for RMC-4630

Finding: The protocol (Sections 7.1 "Investigational Product Administration" and 8.7.3 "Dietary Instructions") mandates that RMC-4630 be administered with a "low-fat meal (approximately 10-15 grams of fat)". However, it lacks specific examples of qualifying meals or clear, standardized instructions for site staff on how to counsel participants effectively and how to document participant adherence to this dietary requirement. This ambiguity presents a practical challenge for CRCs in providing consistent patient education and for sites in accurately capturing compliance, potentially leading to variability in drug absorption and an increase in data queries. Recommendation: Request the Sponsor to develop and provide a supplementary site-facing guidance document or a protocol appendix. This document should include: 1) A list of common, easily accessible food items or simple meal examples that align with the "10-15 grams of fat" criterion. 2) Standardized, patient-friendly talking points for CRCs/site staff to use when counseling participants on adhering to this specific meal type. 3) A clear, simple, and standardized method for documenting participant-reported adherence in source documents and subsequently in the CRF (e.g., a checkbox for "Low-fat meal consumed as instructed: Y/N" based on patient report at the visit, or guidance for a brief dietary recall note specifically for the RMC-4630 administration). Rationale: Providing these resources will significantly enhance participant understanding and consistent adherence to the dietary instructions. This, in turn, will promote uniformity in drug administration conditions across all participants and sites, minimize potential variability in RMC-4630 pharmacokinetics due to dietary deviations, and streamline site documentation processes, ultimately reducing the risk of protocol deviations, data inconsistencies, and subsequent queries related to drug administration.